CLINICAL CENTER:DIET INTERVENTION IN HIGH LDL CHILDREN

这项提议是为了建立一个合作试验的临床中心， 旨在评估可行性、可接受性、有效性和 旨在减少低密度饮食干预的安全性 8~10岁儿童脂蛋白水平的研究 被确认为低密度脂蛋白胆固醇水平升高。 健康研究中心和研究人员已经 进行了与拟议研究相关的各种研究。 其中包括几项饮食干预的合作试验和 行为矫正，以及各种治疗和 降低健康风险示范项目。 波特兰中心的主要参与者来源将是 西北地区凯撒永久会的会员资格。这 HMO注册了30万名成员，约占 都会区。德皇永久会员资格密切相关 与大都市的人口相似。Kaiser Permanente有 有效地成为该公司的主要招聘来源 MRFIT、BHAT和SHEP试验。 在可行性阶段，临床中心将招募和 将20名自由生活的、以前未接受治疗的青春期前儿童随机分组 8-10岁患有高低密度脂蛋白的儿童。这些孩子和 他们的家人将被随机分成饮食干预组 和常规护理对照组。 在全面试验期间，该中心将招募和随机抽取80名 儿童及其家庭的学习和控制小组。这项研究 将为小组提供饮食干预计划，以评估 干预措施的可接受性、有效性和安全性。 因为与健康相关的习惯很难改变， 因为家庭在最初的学习中是一个主要因素 与健康相关的态度和行为，干预是 旨在让儿童和他们的家庭同时参与。

This proposal is for a clinical center in collaborative trial that is designed to assess the feasibility, acceptability, efficacy, and safety of dietary intervention designed to reduce low density lipoprotein (LDL) levels in children ages eight years to ten years identified as having elevated LDL cholesterol levels. The Center for Health Research and the study investigators have conducted a variety of studies relevant to the proposed study. These include several collaborate trials of diet intervention and behavior modification, and a variety of therapeutic and demonstration projects in reducing health risk. The primary source of participants at the Portland Center will be the membership of Kaiser Permanente, Northwest Region. This HMO enrolls 300,000 members, approximately 20% of the Metropolitan Area. The Kaiser Permanente membership closely resembles the metropolitan population. Kaiser Permanente has effectively served as a primary recruitment source for the MRFIT, BHAT, and SHEP trials. The clinical center will, during the feasibility phase, recruit and randomize 20 free-living, previously untreated prepubescent children ages 8-10 with high LDL cholesterol. These children and their families will be randomized into a dietary intervention group and a usual care control group. During the full trial the center will recruit and randomize 80 children and their families to study and control groups. The study group will be offered a diet intervention program, to assess the acceptability, efficacy, and safety of the intervention. Because health-related habits are so resistant to change and because the family is a primary factor in the initial learning of health-related attitudes and behaviors, the intervention is designed to involve children and their families simultaneously.